The Effectiveness of Topical Lidocaine in Relieving Pain Related To Intranasal Midazolam Sedation: A Randomized, Placebo-Controlled Clinical Trial
Overview
- Phase
- Phase 2
- Intervention
- Midazolam
- Conditions
- Burning Nose
- Sponsor
- Tishreen University
- Enrollment
- 63
- Locations
- 1
- Primary Endpoint
- Changes in Pain Scores on the Wong Baker Faces Scale for pain assessment when administering midazolam alone, saline or midazolam premidicated with lidocaine .
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
Aims: The objective of the current study was to evaluate the effectiveness of topical lidocaine in relieving pain related to INM administration.
Design: This was a blinded, randomized placebo-controlled trial. Sixty-three uncooperative children, aged 4 - 11.
Detailed Description
Background and Aims: The use of intranasal midazolam (INM) has been commonly associated with a burning sensation of the nasal mucosa. However, despite its significance, this subject has received little adequate research focus. The objective of the current study was to evaluate the effectiveness of topical lidocaine in relieving pain related to INM administration. Design: This was a blinded, randomized placebo-controlled trial. Sixty-three uncooperative children, aged 4 - 11, were randomly assigned to one of three groups to receive the drug nasally via a pre-calibrated spray as per the following assignments: A: received 0.5 mg/kg midazolam, B: received lidocaine 2% prior to 0.5 mg/kg midazolam. C: received saline 9% (placebo), 0.5mg/kg. Children were asked to record the degree of pain using Wong-Baker-Faces- (WBFS) Scale.
Investigators
Nabih Raslan
Principal Investigator
Tishreen University
Eligibility Criteria
Inclusion Criteria
- •uncooperative children scored 1 or 2 on Frankle Scale.
- •had no medical history of neurological or cognitive alterations.
- •No facial deformities.
- •ASA Classification I.
- •requiring dental treatment under local anesthesia.
Exclusion Criteria
- •known allergy to midazolam or any other benzodiazepines.
- •upper respiratory tract infection with nasal discharge.
Arms & Interventions
A (Midazolam)
21 children received 0.5 mg/kg intranasal medication (midazolam), with a maximum dose of 10 mg, via a spray of 0.2 ml per puff, administering the drug was alternated between the two nostrils of the child.
Intervention: Midazolam
B (Lidocaine-Midazolam)
21 children received a puff of lidocaine 2% in each nostril, after 60 seconds, they received 0.5 mg/kg intranasal medication (midazolam),administering the drug was alternated between the two nostrils of the child, with a maximum dose of 10 mg via a spray of 0.2 ml per puff.
Intervention: Lidocaine-Midazolam
C (Placebo)
21 children received intranasal medication (saline 9% as placebo), 0.5 mg/kg, with a maximum dose of 10 mg via a spray of 0.2 ml per puff,administering the drug was alternated between the two nostrils of the child.
Intervention: Placebo
Outcomes
Primary Outcomes
Changes in Pain Scores on the Wong Baker Faces Scale for pain assessment when administering midazolam alone, saline or midazolam premidicated with lidocaine .
Time Frame: one to five minutes following the administration.
The use of intranasal midazolam is associated with a burning sensation of the nasal mucosa, the pain was assessed using a self report pain scale Wong Baker Faces Scale, the degree of pain is determined by choosing a score of (0-2-4-6-8-10) (minimum score 0, means no pain, maximum score 10, means the drug hurts worst, higher scores are worse) the scores were reported by children received intranasal midazolam alone, intranasal midazolam preceded by intranasal lidocaine or intranasal saline (placebo).